A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

July 31, 2008

Conditions
Melanoma
Interventions
DRUG

Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)

Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)

Trial Locations (12)

31052

Toulouse

33000

Bordeaux

39373

Lyon

94805

Villejuif

CB2 0QQ

Cambridge

SO16 6YD

Southampton

NW3 2QG

London

SE1 7EH

London

SW3 6JJ

London

M20 4BX

Manchester

HA6 2RN

Northwood

SM2 5PT

Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY